Protocol summary
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Study aim
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To compare the effects of single dose suprachoroidal triamcinolone acetonide injection combined with three monthly intravitreal injections of bevacizumab with only 3 monthly intravitreal bevacizumab injections on center involving diabetic macular edema in patients with non-proliferative diabetic retinopathy.
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Design
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Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
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Settings and conduct
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In this randomized, double-blind, two-arm, parallel-group controlled trial which will be held in Feiz eye hospital, we want to evaluate the effects of injecting a single dose triamcinolone acetonide in suprachoroidal space combined with 3 monthly intravitreal bevacizumab injections in patients with non-proliferative diabetic retinopathy with center involving diabetic macular edema.
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Participants/Inclusion and exclusion criteria
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Patients with non-proliferative diabetic retinopathy with center involving diabetic macular edema with best corrected visual acuity ≤ 20/40.
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Intervention groups
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1- In the intervention group, 0.1 cc triamcinolone acetonide will be injected in suprachoroidal space combined with intravitreal bevacizumab in the first injection. Intravitreal bevacizumab alone will be injected in the second and third injections.
2- In the control group, combined with injecting intravitreal bevacizumab, a sham injection (pressing the sclera with the same needle) will be performed to simulate the suprachoroidal injection in the first sesson. Intravitreal bevacizumab alone will be injected in the second and third injections exactly the same as the intervention group.
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Main outcome variables
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1- Mean changes in best corrected visual acuity
2- Mean changes in central macular thickness
3- Mean changes in central macular volume
4- Mean changes in intraocular pressure
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200314046761N1
Registration date:
2020-03-21, 1399/01/02
Registration timing:
registered_while_recruiting
Last update:
2020-11-21, 1399/09/01
Update count:
1
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Registration date
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2020-03-21, 1399/01/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-09-23, 1398/07/01
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Expected recruitment end date
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2020-05-20, 1399/02/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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To evaluate the effect of single dose suprachoroidal triamcinolone acetonide injection combined with three monthly intravitreal injection of bevacizumab on center-involving diabetic macular edema in patients with non-proliferative diabetic retinopathy compared to the control group.
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Public title
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Effect of single dose suprachoroidal triamcinolone acetonide injection on diabetic macular edema.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with non-proliferative diabetic retinopathy with center-involving diabetic macular edema with best corrected visual acuity ≤ 20/40.
Patients have not received any interventions (Intravitreal injection, laser, intraocular surgery) 3 months prior to the recruitment.
No history of deep vitrectomy.
Exclusion criteria:
Other comorbid conditions such as CNV, RVO, Glaucoma etc.
Pregnancy
Significant cataract
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Age
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From 18 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
59
More than 1 sample in each individual
Number of samples in each individual:
2
If eligible, each of the eyes of a single patient is included in the trial as one case.
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Eligible eyes were randomly assigned into 2 group ( intervention, control) using random block permutation software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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1- At the onset, patients are completely informed about the trial and randomization process and they are blinded to the grouping.
2- The researcher cannot be blinded because he performs all the interventions himself. However, mean best corrected visual acuity changes as the primary outcome are measured by a blinded resident. Central macular thickness (CMT), central macular volume (CMV) etc. as the secondary outcomes are measured by automatic spectral domain optical coherence tomography (SD-OCT) by a trained blinded technician.
3- The statistical analyst is blinded to the grouping.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-11-02, 1398/08/11
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Ethics committee reference number
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IR.MUI.MED.REC.1398.410
Health conditions studied
1
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Description of health condition studied
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Center-involving diabetic macular edema
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ICD-10 code
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E08.311
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ICD-10 code description
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Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema.
Primary outcomes
1
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Description
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Mean change in best corrected visual acuity (BCVA)
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Timepoint
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Baseline (Day 0), a month after third intravitreal injection (Day 90-95)
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Method of measurement
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1- Snellen chart 2- Early Treatment Diabetic Retinopathy Study (ETDRS) letters
Secondary outcomes
1
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Description
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Mean changes in central macular thickness
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Timepoint
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Baseline (Day 0), a month after third intravitreal injection (Day 90-95)
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Method of measurement
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Spectral domain optical coherence tomography
2
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Description
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Mean changes in central macular volume
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Timepoint
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Baseline (Day 0), a month after third intravitreal injection (Day 90-95)
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Method of measurement
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Spectral domain optical coherence tomography
3
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Description
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Mean changes in intraocular pressure
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Timepoint
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Baseline (Day 0), day 30, a month after third intravitreal injection (Day 90-95)
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Method of measurement
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Applanation tonometry
Intervention groups
1
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Description
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Intervention group: Single dose suprachoroidal triamcinolone acetonide (4 mg / 0.1 cc) injection using custom made needle + intravitreal bevacizumab (1.25 mg / 0.05 cc) injections for 3 consecutive months
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Category
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Treatment - Drugs
2
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Description
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Control group: simulating suprachoroidal injection (sham injection: pressing the sclera with the same gauge needle without entering the sclera) in the first injection + intravitreal bevacizumab (1.25 mg / 0.05 cc) injections for 3 consecutive months
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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After the patients have been unrecognized, full data can be shared.
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When the data will become available and for how long
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The requests will be accepted at least 6 months after publishing the last results.
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To whom data/document is available
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Researchers in the field of ophthalmology
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Under which criteria data/document could be used
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From where data/document is obtainable
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Mohammadeza Fazel
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What processes are involved for a request to access data/document
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Sending an email including the reason of request and personal curriculum vitae.
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Comments
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